Our Presence
USA | India
Email Us
info@atvigilx.com
Home
About us
Services
Pharmacovigilance Services
Case Management & Processing
Medical Writing
Single service
PV Quality & Compliance
Clinical safety Management
Pharmacovigilance Consulting
Signal & Risk Management
Development & Implementation
Adverse Event Intake
Regulatory Affairs Services
Regulatory Strategies Consulting Services
New Product Marketing Authorizations
Regulatory Gap Analysis & Remediation
Regulatory Due Diligence
ANDA and MA Holder Services
API/DMF – Drug Safety
CMC Regulatory Advisory
eCTD Publishing & Submission Services
Pharmaceutical Product labelling Services
GCP Services
Audit
Clinical Trial Monitoring
Bioanalytical Monitoring
Bioequivalence Study monitoring
Pharmacovigilance (PV) Services:
Case Management & Processing:
Data Migration
ICSR Management
Literature Screening and Review
Medical Review of ICSRs
Submissions
Medical Writing:
Aggregate Reports
Protocol Review
Risk Management Reports
Risk Management Plans (RMP)
Periodic safety update report (PSUR)
Benefit risk evaluation reports
Patient safety summaries/ narratives
Summary product characteristics (SPC)
Package Inserts
Pharmacovigilance Consulting:
PV Benchmarking
PV Training
PV Management Consulting
Regulatory Intelligence
PV Quality & Compliance:
Eudravigilance Setup & Maintenance
PSMF Setup & Maintenance
PV Audit-as-a-service
QPPV Services
SOP Development
Clinical Safety Management:
Drug Safety & Reporting Training
SAE and SUSAR Management
Safety Management Plan
Signal & Risk Management:
Benefit Risk Management
Drug Safety Physician Services
Regulatory Responses
Signal Detection and Management
Development & Implementation
Adverse Event Intake
Local Pharmacovigilance
Medical Device vigilance
Medical Information Call Centre
Regulatory Affairs Services:
Regulatory Strategies Consulting
New Product Marketing Authorizations
Regulatory Gap Analysis & Remediation
Regulatory Due Diligence
API/DMF - Drug Safety
CMC Regulatory Advisory
ANDA & MA Holder
eCTD Publishing & Submission
Pharmaceutical Product labelling
GCP Services:
Audit
Clinical Trial Monitoring
Bioanalytical Monitoring
Bioequivalence Study monitoring
Portfolio
Pharmaceuticals
Medical Device
Biological & Biosimilar
Herbals
Dietary Supplements
FDA
CDSCO
Health Canada
EMA
MHRA
Blog
Contact
Careers
X
RFP/RFI
Atvigilx Knowledge Hub
Explore insights and expertise at the Atvigilx Knowledge Hub.
13
Nov
The Importance of Regulatory Gap Analysis Services for Effective Risk Management.
Read More
13
Nov
Navigating Global Regulations with Pharmacovigilance Regulatory Intelligence
Read More
08
Nov
Why Regulatory Gap Assessment Is Crucial for Global Pharma Markets?
Read More
07
Nov
Top pharmacovigilance consultancies and companies in the USA and India.
Read More
09
Sep
How Signal Pharmacovigilance Protects Patient Safety: Navigating Risks
Read More
06
Sep
Good Clinical Practice in Pharmacovigilance: A Guide to Drug Safety Compliance.
Read More
26
Jun
Navigating Regulatory Changes in Pharmacovigilance: A Comprehensive Guide.
Read More
26
Jun
Implementing AI and Machine Learning in Pharmacovigilance Practices.
Read More
26
Jun
Patient-Centered Approaches in Modern Pharmacovigilance.
Read More
26
Jun
Best Practices for Ensuring Data Integrity in Pharmacovigilance
Read More
26
Jun
Challenges and Solutions in Signal Detection in Pharmacovigilance
Read More
26
Jun
Emerging Trends in Real-World Evidence and Pharmacovigilance
Read More
Search By Categories
Subscribe Newsletter
Please leave this field empty.
Recent Posts
The Importance of Regulatory Gap Analysis Services for Effective Risk Management.
November 13, 2024
Navigating Global Regulations with Pharmacovigilance Regulatory Intelligence
November 13, 2024
Why Regulatory Gap Assessment Is Crucial for Global Pharma Markets?
November 8, 2024
Top pharmacovigilance consultancies and companies in the USA and India.
November 7, 2024
How Signal Pharmacovigilance Protects Patient Safety: Navigating Risks
September 9, 2024
Categories
Categories
Select Category
News (5)
Pharmacovigilance (3)
Regulatory Affairs (2)
Uncategorized (2)
Archives
Archives
Select Month
November 2024 (4)
September 2024 (2)
June 2024 (6)